FDA 510(k) Application Details - K211618

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K211618
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	The Surgical Company International B.V. Beeldschermweg 6F Amersfoort 3821 AH NL Other 510(k) Applications for this Company
Contact	Inette Nieveen Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2021
Decision Date	06/05/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review